Agency classClass IIOur severity:Severe FDA (Drugs)·D-0131-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

JD & SN Inc. is recalling 120 mg testosterone pellets because the company cannot ensure the sterile compounded drugs are free from contamination.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility failures in compounded drugs are categorized as Severe.

Plain-English summary

JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling 120 mg testosterone pellets. The recall was initiated because the company lacks assurance of the sterility of the sterile human compounded drugs within their expiration dates.

The affected product is a prescription-only medication consisting of 20 pellets per unit. The recall covers specific lots identified by codes ranging from t01142015 to t12052014. The distribution pattern for these products is nationwide.

Consumers who have purchased these specific lots of testosterone pellets should stop using them and contact their healthcare provider or the recalling pharmacy for further instructions.

The recalled product

Product: TESTOSTERONE, Pellet, 120 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
Manufacturer: JD & SN Inc., dba Moses Lake Professional Pharmacy
Category: Drug — Compounded Sterile Drug
Hazard: sterility-failure
infection-risk
Affected units: 20

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

t12052014@18
t11252014@19
t11192014@18
t11112014@4
t09192014@18
t09102014@20
t08272014@10
t06242015@30
t06022015@8
t05202015@11
t05042015@22
t05012015@17
t04102015@4
t03302015@21
t03202015@18
t03052015@12
t02252015@10
t01302015@23
t01232015@24
t01142015@21.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 101 products in this recall →

Same manufacturer · JD & SN Inc., dba Moses Lake Professional Pharmacy

See all →

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Same hazard · sterility failure